Clinical Research Directory

The UGIRA International Registry for RAMIG for Gastric Cancer

Minimally invasive gastrectomy (MIG) has gained in popularity, since it is feasible, safe and oncologically comparable to open gastrectomy, while morbidity and duration of hospitalization are reduced, quality of life is increased, and conversion rate is low. However, several challenges are faced during MIG, such as impaired depth perception and limited range of motion of instrument tips. Robot-Assisted Minimally Invasive Gastrectomy (RAMIG) can potentially overcome these challenges, while providing comparable results regarding safety, technical feasibility, morbidity and oncological effectiveness. However, the techniques and outcomes of RAMIG vary in literature, which can partly be explained by lack of uniform definitions of postoperative outcomes that would allow international comparison. Furthermore, RAMIG is technically demanding and therefore associated with a learning curve. To facilitate safe and effective implementation of RAMIG worldwide, the learning curve for RAMIG-procedures must be evaluated in detail. A prospective international registry with uniform data collection regarding surgical techniques and postoperative outcomes can provide a platform for multicontinental studies and the monitoring of surgical quality for surgeons who are implementing RAMIG in their center. Therefore, the aim of this study proposal is to expand the Upper Gastrointestinal International Robotic Association (UGIRA) collaboration by creating the UGIRA International Registry for RAMIG. The UGIRA network extends worldwide with members in Europe, Asia, North-America and South-America, therefore representing large-scale practice of RAMIG. The initial specific aims of the registry are to gain insight in surgical techniques and postoperative outcomes of RAMIG worldwide, and to evaluate the learning curve for RAMIG. Data for this registry is collected prospectively and retrospectively.

Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.

The Pancreatic Enzymes After Gastrectomy Trial

This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.

Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection. Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.

How Epigenetic Changes in hMLH1 Connect Lab Research With Diagnosis in Gastric Cancer

DNA methylation is one of the key mechanisms that are thought to underlie the association between aging and cancer. Several methylation-based measures of biological aging have been developed and have demonstrated an association with mortality and, in some cases, with cancer incidence. Accordingly, CpG promoter hypermethylation is a well-known mechanism of gene inactivation in carcinogenesis. Gastric cancer has been classified in different molecular phenotypes based on genetic and epigenetic characteristics. One of these subtypes is characterized by a high grade of microsatellite instability (MSI-H). In gastric cancer, the MSI-H status is mostly caused by methylation of the hMLH1 gene promoter (between 71% and 78%), that is also considered the representative of a gastric-specific CpG island methylation pattern (CIMP). Gastric cancer with hMLH1 hypermethylation is frequently expressed in the MSI-H phenotype but also reported in the MSI-L type. Hypermethylation has been associated with advanced age, dietary habits, smoking and alcohol consumption. Moreover, other studies on GI cancer (colorectal, rectal and gastric) have associated hMLH1 hypermethylation with decreased levels of folate, vitamin C and niacin. Last, increased oxidative stress has been proposed as one of the possible initiators of cancer development and progression through epigenetic mechanism as hypermethylation. From a clinical standpoint, MSI-H gastric cancers have been associated with increased resistance to standard chemotherapy and increased immunogenicity, representing a hypothetic ideal target to immunotherapy, that has documented clinical efficacy for this subtype. However, some authors have suggested that MSI-H GCs without hMLH1 hypermethylation and GCs with hMLH1 hypermethylation could be different in terms of clinicopathologic characteristics and biological behavior. In addition, the specific role of hMLH1 hypermethylation in resistance to standard chemotherapy is unknown, as well as its potential adjunctive role in the chemoresistance of hypermethylated - but MSI-L - tumors. Identifying risk factors for hMLH1 hypermethylated GC could have relevant implications in terms of disease prevention and even reversal of the hypermethylation mechanisms through natural as well as synthetic compounds. It could also identify a predictive tool to better stratify patients for expected sensitivity to specific chemotherapy (or biological therapy) regimens. Therefore, this preliminary study aims to determine if the development of hMLH1-methylated GC is associated with specific clinicopathologic characteristics and environmental habits. It also aims to report on the biological behavior of these tumors, as well as on their chemosensitivity to platin-based chemotherapy regimens.

Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery

This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care ultrasound (POCUS). The pre-operative imaging will be done post-intubation and the post-operative imaging will be done pre-extubation. There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under general anesthesia at the time of imaging.

Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy

Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established. Hand-sewn anastomosis relies on advanced endoscopic suturing skills, making it technically demanding and only performed in a limited number of hospitals. Linear anastomosis is simple to perform and the most widely used in clinical practice. However, it requires resection of a longer segment of the distal esophagus and may struggle to ensure adequate margins for high-positioned tumors or unclear resection boundaries. Circular anastomosis is a classic method. Its end-to-side approach preserves more esophageal length, making it suitable for high-positioned tumors without the need to close a common opening. Various techniques (e.g., the reverse-puncture method and the Orvil™ transoral anvil technique) have been reported. However, due to challenges such as purse-string suturing, complex anvil placement, and restricted stapler maneuverability, widespread adoption remains difficult. Prof. Du Jianjun's team innovatively employed endoscopic purse-string forceps and a multifunctional sealing ring to achieve circular anastomosis, demonstrating preliminary technical advantages. This study further explores its feasibility and short-term outcomes in totally endoscopic total gastrectomy.

Reduced Port Laparoscopic Gastrectomy for Gastric Cancer

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy

Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery: 1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery. 2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

The Impact of Laparotomy and Analgesia Methods on Diaphragm

Major abdominal surgeries are traditionally performed via laparotomy. Analgesia is routinely administered during the postoperative period. The goal is to investigate the effects of laparotomy and analgesia methods on diaphragm function.

A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery

The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.

The Influence of Splenic Artery Characteristics in Gastric Cancer Surgery

The northwest Chinese population has unique anatomical characteristics of splenic artery due to ethnic differences, which has an important impact on the development and prognosis of laparoscopic radical total gastrectomy.

The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)

Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.

Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.